FONDAPARINUX SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fondaparinux sodium (UNII: X0Q6N9USOZ) (FONDAPARINUX - UNII:J177FOW5JL)

Available from:

Italfarmaco S.p.A

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. Fondaparinux sodium injection is contraindicated in the following conditions:(4) - Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions (5.3) and Use in Specific Populations (8.6).] - Active major bleeding. - Bacterial endocardi

Product summary:

Fondaparinux Sodium Injection USP is available in the following strengths and package sizes: 2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with blue plunger rod. 5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x½-inch needle and an automatic needle protection system with orange plunger rod. 7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x½-inch needle and an automatic needle protection system with magenta plunger rod. 10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x½-inch needle and an automatic needle protection system with violet plunger rod. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)  [See USP Controlled Room Temperature.] Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FONDAPARINUX SODIUM- FONDAPARINUX SODIUM INJECTION, SOLUTION
ITALFARMACO S.P.A
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FONDAPARINUX SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FONDAPARINUX SODIUM INJECTION.
FONDAPARINUX SODIUM INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
WARNING: SPINAL/EPIDURAL HEMATOMAS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE
ANTICOAGULATED WITH LOW MOLECULAR WEIGHT
HEPARINS (LMWH), HEPARINOIDS, OR FONDAPARINUX SODIUM AND ARE RECEIVING
NEURAXIAL ANESTHESIA OR
UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR
PERMANENT PARALYSIS.
CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
FACTORS THAT CAN INCREASE THE RISK OF
DEVELOPING EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE:
USE OF INDWELLING EPIDURAL CATHETERS
CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS), PLATELET INHIBITORS, OR OTHER ANTICOAGULANTS
A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURE
A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGIC
IMPAIRMENT. IF NEUROLOGIC
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY.
CONSIDER THE BENEFIT AND RISKS BEFORE NEURAXIAL INTERVENTION IN
PATIENTS ANTICOAGULATED OR TO BE
ANTICOAGULATED FOR THROMBOPROPHYLAXIS. _[SEE WARNINGS AND PRECAUTIONS
(5.1) AND DRUG INTERACTIONS (7).]_
INDICATIONS AND USAGE
Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant)
indicated for:
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip
fracture surgery (including extended
prophylaxis), hip replacement surgery, knee replacement surgery, or
abdominal surgery. (1.1)
Treatment of DVT or acute pulmonary embolism (PE) when administered in
conjunction with warfarin. (1.2, 1.3)
DOSAGE AND ADMINISTRATION
Fo